Synchron, the startup behind an FDA breakthrough neuroprosthesis device that aims to give patients with paralysis the ability to control digital devices with their thoughts, has been cleared by the FDA to begin a clinical trial with human participants.

Called the COMMAND trial, the study will take place later this year at Mount Sinai Hospital in New York and will include six patients with severe paralysis. Carnegie Mellon University and the University of Pittsburgh Medical Center are also collaborating with Synchron on the trial.

Synchron is looking to assess the safety and efficacy of its Stentrode device in using brain data to control digital devices and achieve improvements in functional independence. Ideally, the company hopes this study will be a stepping stone towards regulatory approval of its product.

“The approval of this [Investigational Device Exemption] reflects years of safety testing performed in conjunction with FDA,” Dr. Thomas Oxley, CEO of Synchron, said in a statement.

“We have worked together to pave a pathway forward, towards the first commercial approval for a permanently implanted [brain computer interface] for the treatment of paralysis. We are thrilled to finally be launching a U.S. clinical trial this year.”

The Stentrode device is implanted into the motor cortex of the brain through the jugular vein in a minimally invasive procedure that the company says takes about two hours. Once implanted, it translates brain activity into a standardized digital language to allow users to complete tasks on external devices, including texting, emailing, online shopping and accessing telemedicine.

WHY IT MATTERS

In 2013, nearly 5.4 million people in the U.S. were living with paralysis, according to the American Journal of Public Health. It found that stroke was the leading cause of paralysis, followed by spinal cord injury, multiple sclerosis and cerebral palsy.

The journal stressed the need for targeted interventions to address the functional limitations of paralyzed individuals, which is where Synchron hopes to come in.

The company sets itself apart from others that are creating brain-computer interface implants, like Elon Musk’s Neuralink, in that its implantation procedure is less invasive. It says that other companies’ approaches involve drilling into the skull to embed electrodes, which can cause “long-term brain inflammation.”

Synchron also distances itself from the pack by testing its implant in humans, something that Neuralink has yet to begin. In fact, Synchron has already begun studying the effects of Stentrode among patients with paralysis in Australia. Data from the first two patients in the study were published in the Journal of NeuroInterventional Surgery last October. They showed that the participants could type on their devices with only their thoughts.

THE LARGER TREND

Earlier this year, Synchron scored $40 million in Series B funding for its implantable brain-computer interface tech.

Although it hasn’t begun human-testing yet, Neuralink demoed its product in pigs last summer and shared that it had received FDA Breakthrough Device designation, with hopes to begin human testing “soon.”

Paradromics is another startup working to create streaming capabilities between the brain and computers. It raised $20 million in a seed funding round announced last week.

Brain-computer interface technology is also being studied to restore speaking capabilities in people with paralysis, and earlier this month a Facebook-backed study demonstrated that it could translate brain activity into words and sentences in real time.

ON THE RECORD

“Synchron’s north star is to achieve whole-brain data transfer,” Oxley said.

“The blood vessels provide surgery-free access to all regions of the brain, and at scale. Our first target is the motor cortex for treatment of paralysis, which represents a large unmet need for millions of people across the world, and market opportunity of $20 billion.”